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The effect of Broncho-Vaxom on the COPD exacerbations in terms of lung function, lung mechanics, immune state, body composition, quality of life and physical activity.
EU CTIS ID: 2025-524501-32-02
What this study is testing
To evaluate the efficacy of Broncho-Vaxom in reducing the rate of moderate (managed at home) and severe (requiring hospitalization) exacerbations in COPD patients during the 6-month treatment period and the subsequent 6-month observation phase.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has confirmed diagnosis of COPD.
- The participant provides documented informed consent/assent for the study.
- At least two moderate or one severe exacerbations requiring hospitalization (for 3 days steroid therapy or antibiotic therapy due to exacerbation), despite adherence to standard treatment as outlined in the GOLD guidelines
- FEV1>20%pred and FEV1<70%pred
- BMI: 18 kg/m2 – 40 kg/m2
- Female and male patients between 40 years and 80 years.
You likely can't join if
- Patients with inadequate compliance with standard therapies for COPD.
- Patients who are unable to walk enough distance to come to the visit.
- Patients who take immunosuppressants or oral corticosteroids within 1 month before entering the study.
- Patients who take antibiotics within 4 weeks before entering the study.
- Patients who take bacterial lysate in the previous 12 months at least 4 weeks before entering the study.
- Has a hypersensitivity to Broncho-Vaxom.
See the full eligibility criteria
- Has confirmed diagnosis of COPD.
- The participant provides documented informed consent/assent for the study.
- At least two moderate or one severe exacerbations requiring hospitalization (for 3 days steroid therapy or antibiotic therapy due to exacerbation), despite adherence to standard treatment as outlined in the GOLD guidelines
- FEV1>20%pred and FEV1<70%pred
- BMI: 18 kg/m2 – 40 kg/m2
- Female and male patients between 40 years and 80 years.
- Heavy smoking anamnesis: >20 years smoking history
- Not reversible <12%pred FEV1 with reversibility test
- Male participants agree to use contraception method through the study conduct
- Contraceptive use by women and men should be consistent with local regulation regarding the methods of contraception for those participating in studies.
- Patients with inadequate compliance with standard therapies for COPD.
- Patients who are unable to walk enough distance to come to the visit.
- Patients who take immunosuppressants or oral corticosteroids within 1 month before entering the study.
- Patients who take antibiotics within 4 weeks before entering the study.
- Patients who take bacterial lysate in the previous 12 months at least 4 weeks before entering the study.
- Has a hypersensitivity to Broncho-Vaxom.
- Has a history or current evidence of any condition, therapy or laboratory abnormality or other circumstances that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, such that is not in the best interest of the participant to participate, in the opinion of the investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.